top of page

EMA: QRD updation and Product-Information Templates Updation

The European Medicines Agency released an updated template on QRD and updated its page on "Product-information templates - Human".

The QRD initiative was launched in 1999 to harmonize the format and content of product information for medicinal products in the EU.

The first version of the QRD templates was published in 2001, and they have been regularly updated since then to reflect changes in regulatory requirements and best practices.

The European Medicines Agency's (EMA) Working Group on Quality Review of Documents (QRD) develops, reviews and updates templates for product information for use by applicants and marketing authorisation holders for human medicines.

The QRD template v10.4 was revised to delete 'United Kingdom (Northern Ireland)' from the list of local representatives in the package leaflet to comply with the Windsor Framework for labelling and packaging of medicines. 

When to Use QRD:

  • Use QRD templates when submitting applications for marketing authorization in the EU.

  • Use QRD templates when updating product information documents due to changes in regulatory requirements or product information.

Why to Use QRD:

The use of QRD, Ensures consistent and high-quality product information across the EU and facilitates the regulatory review process. Also provides clear and concise information to patients and healthcare professionals which helps to comply with EU regulatory requirements.

How to Use QRD:

  • Use the QRD templates for the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and Labelling.

  • Follow the instructions and guidelines provided in the QRD templates.

  • Submit the product information documents in the specified format.

You can download and view the recent versions by clicking the below links

Check out this page on Product-information templates - Human for more detailed information to QRD.


bottom of page